The Recall Desk
HighFDA (Devices)·Z-0365-2022·Announced 2021-12-22

Orthopedic Femur Plate Recalled for Incorrect MRI Safety Information

Smith & Nephew is recalling 35 units of EVOS Condylar Medial Distal Femur Plate due to incorrect MRI scanning safety information in the product instructions. The instructions contained erroneous data that could affect patient safety during MRI procedures.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of a medical device with incorrect MRI safety information documented in the Instructions for Use, with no reported illnesses or injuries. The hazard is potential risk of harm if the device is exposed to MRI procedures using the incorrect safety parameters.

Plain-English summary

Smith & Nephew, Inc. is recalling 35 units of the EVOS Condylar Medial Distal Femur Plate, a surgical implant used in orthopedic procedures. The affected units are identified by batch numbers 20HM10252, 20HM10253, 20HM10254, and 20HM22785.

The recall was initiated after a testing vendor notified Smith & Nephew that MRI scanning safety conditions provided in testing reports were erroneous. This faulty testing data was incorporated into the product's Instructions for Use (IFU 81110294 for the EVOS Large Fragment Plating System), resulting in incorrect MRI safety information being provided to users.

The affected product was distributed nationwide in Colorado, Florida, Georgia, Massachusetts, Minnesota, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, and Washington.

The recalled product

Product
smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102
Manufacturer
Smith & Nephew, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
35

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Batch Number: 20HM10252
  • 20HM10253
  • 20HM10254
  • 20HM22785
  • UDI

Distribution

Distributed nationwide across the United States.

The notice also names 16 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Smith & Nephew, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Related recalls

Same manufacturer · Smith & Nephew, Inc.

See all →